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CTRI Number  CTRI/2017/03/008123 [Registered on: 16/03/2017] Trial Registered Retrospectively
Last Modified On: 10/03/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Laryngoscopic view with different operating table height.  
Scientific Title of Study   Influence of operating table height on laryngeal view during direct laryngoscopy: A randomized prospective crossover trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr kailashnath Shenoy 
Designation  Professor 
Affiliation  Kasturba Medical College , Manipal 
Address  Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  kailasnathshenoy@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yogesh K Gaude 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College , Manipal 
Address  Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  yogeshgaude@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kriti Puri 
Designation  Junior Resident 
Affiliation  Kasturba Medical College , Manipal 
Address  Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  drkriti1207@gmail.com  
 
Source of Monetary or Material Support  
PG Thesis fund , Manipal University, Manipal, Karnataka , India. 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kailashnath Shenoy  Kasturba Hospital, Manipal  Department of Anaesthesiology, OT Complex, Kasturba Hospital,Manipal University, Madhavnagr, Manipal
Udupi
KARNATAKA 
08904380406

kailasnathshenoy@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kasturba Hospital, Manipal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  American Society Of Anesthesiologists physical status 1 and 2,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laryngoscopy view above xiphoid process   Group A- Initial laryngoscopy with table height adjusted to place patient’s forehead at a level 5cm below xiphoid process (level B). Following this the operating table height will be brought to the level of xiphoid process (level X) in accordance to level marked beforehand on the IV stand. Subsequent laryngoscopy and intubation with table height adjusted to place patient’s forehead 5 cm above the level of laryngoscopist’ xiphoid process (level A).  
Comparator Agent  Laryngoscopy view at xiphoid process  Group X - Initial laryngoscopy will be performed at level B. Subsequently operating table height will be adjusted to level A and laryngoscopy will be performed. Next the table will be brought to level X and laryngoscopy and intubation will be done at this level. 
Comparator Agent  Laryngoscopy view below xiphoid process  Group B – Initial laryngoscopy with table height adjusted to place patient’s forehead 5cm above the level of laryngoscopist’ xiphoid process (level A). Next the level of the operating table will be brought to the level of xiphoid process and laryngoscopy will be performed (level X). Subsequent laryngoscopy and intubation with table height adjusted to place patient’s forehead 5 cm below the level of laryngoscopist’ xiphoid process (level B). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Age between 18-60 years of either sex
2) ASA PS 1 and 2
3) BMI 25 to 30 kg/m2
4) Elective general surgical or gynecological abdominal, urologic or orthopedic surgery requiring general anesthesia.
 
 
ExclusionCriteria 
Details  1) Those aged <18 or >60 years
2) Patients who are obese( Body mass index > 30)
3) Patients with congenital or acquired airway abnormalities
4) Those with loose teeth ,buck teeth or edentulous jaws
5) Those with increased risk of aspiration
6) Those with anticipated difficult airway as evidenced by modified Mallampati Class 3 or 4, inability to insinuate tip of 1 finger into temporo-mandibular joint, mouth opening < 2 finger breadth, thyromental distance < 3 finger breadth.
7) Oropharyngeal/neck masses.
8) Limited neck movement
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Quality of the laryngeal view   During Layngoscopy 
 
Secondary Outcome  
Outcome  TimePoints 
Ease of intubation and anesthesiologist’s comfort   During Layngoscopy 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/10/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

    Maintenance of a patent airway is a fundamental responsibility of the anesthesiologist. Tracheal intubation remains one of the commonest means of establishing an airway. Placing the head and neck in the sniffing position has traditionally been considered important for obtaining good glottic visualization during direct laryngoscopy. Direct laryngoscopy is used to facilitate tracheal intubation under vision. Successful direct laryngoscopy depends on achieving a line of sight from the maxillary teeth to the larynx 1.It has been clearly established in several studies that proper positioning of head and neck is one of the most important step towards laryngoscopy and tracheal intubation which helps in obtaining a good glottic view, thus minimizing the rate of tracheal injury, duration of the procedure, repeated attempts at laryngoscopy and intubation- ultimately reducing the overall rate of trauma and further complications. Best laryngoscopic views are obtained when oropharyngo-laryngeal axes come in a straight line. The ‘sniff’ position has been advocated as a standard for direct laryngoscopy. In this position, the neck is flexed on the chest and the head is extended on the atlanto-occipital joint by elevating the head on a pillows 2,3.The ‘sniff’ position is usually the best starting position for direct laryngoscopy. In the ‘sniff’ position, the cervical spine below C5 is relatively straight, there is increasing flexion from C4 to C2, and the head is fully extended (occipito– atlanto–axial complex) 4. Neck flexion between C2 and C4 is achieved by elevation of the head.

Operating table height can influence task performance and physical/mental workload5, 6 .There have been few studies of the correlation between the operating table height and the quality of laryngeal view during direct laryngoscopic (DL) intubation7. In an editorial on anesthesiologist stature and patient positioning, Heath7 highlighted the benefits of using an adjustable operating table and the ergonomic benefits of different heights—high during cannulation to prevent back discomfort, a bit lower for airway management, and even lower for short trainees. It has been suggested that the patient’s face should be placed at the height of the anesthesiologist’s xiphoid process for comfortable intubation without requiring the anesthesiologist to bend his/her back 8-10 and that the physician’s eyes should be placed 1 foot (30 cm) above the patient’s face to provide proper angles and distances for laryngoscopy 11. However, these results are based on clinical experience rather than scientific validation.

The aim of this study was to evaluate the quality of the laryngeal view (primary variable), ease of intubation and anesthesiologist’s comfort (secondary variable) associated with three different operating table heights during DL and tracheal intubation. Based on our clinical experience, we hypothesized that higher operating tables would improve the quality of the laryngeal view and decrease anesthesiologist’s discomfort during tracheal intubation by reducing the need to bend their neck or lower back when compared with lower operating table height.  
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